Course Overview
This course is similar to CRPT5009 but is designed for people without access to a research centre or to an experienced preceptor. Complete a virtual study start up using a study protocol you provide or one included with the course. You are expected to demonstrate your skills as a CRP by preparing the documentation and processes necessary to complete the start up phase of a clinical trial with minimal input from BCIT faculty. This is your opportunity to apply skills from prior courses to write a POS, obtain ethics approval, prepare the marketing strategy for subject recruitment and define the criteria of a qualified CRP. The completed project must meet all GCP criteria including Health Canada regulations, ICH guidelines and the FDA regulations for clinical research conduct
Prerequisite(s)
- 18-21 credits from Clinical Research Program.
Credits
3.0
- Retired
- This course has been retired and is no longer offered. Find other Flexible Learning courses that may interest you.
Learning Outcomes
Upon successful completion of this course you should be able to prepare and implement the following documents and/or procedures for any clinical research protocol:
- Create a project overview statement and network diagram to enable you to complete a study on time and on budget.
- Determine the scientific and ethical integrity of a protocol.
- Prepare and submit an ethics application.
- Write the operating procedures for the ethics application process.
- Prepare the marketing campaign for subject recruitment.
- Develop the metrics to monitor study subjects retention for a study.
- Develop a plan/guidelines for creating a partnership approach for working with each of the major players in clinical research (how to avoid conflict).
- Design worksheets and source documents.
- Identify the competencies and skills of 'an appropriately qualified' CRP (according to ICH Guideline 4.1.5).
- Each document and/or process will conform with ICH guidelines and FDA regulations.
Effective as of Fall 2003
Programs and courses are subject to change without notice. Find out more about BCIT course cancellations.